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The epothilone B analogue ixabepilone in patients with advanced hepatobiliary cancers: a trial of the University of Chicago Phase II Consortium
Investigational New Drugs, 08/20/09
Nimeiri HS et al. - In a study to evaluate the activity and safety of ixabepilone in a trial in pts with advanced cancers of the gallbladder, bile duct, and liver, it was reported that single-agent ixabepilone has limited activity in advanced hepatobiliary cancers.
Methods- Eligible pts had previously-untreated, histologically-proven unresectable hepatobiliary cancer.
- Ixabepilone, 40 mg/m2, was administered intravenously over 3 hr every 21 days.
- 54 pts (19 hepatocelluar carcinoma, 13 cholangiocarcinomas, 22 gallbladder carcinomas) were enrolled; 47 pts were evaluable for efficacy.
- The objective response rate was 8.5%; 51% had stable disease.
- Median overall survival was 7.0 mos and median progression-free survival was 2.6 mos.
- Grade 3/4 toxicities included neutropenia (39%), fatigue (9%), allergic/hypersensitivity reaction (4%), and sensory neuropathy (4%).
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